With the prevalence of Covid, on 11th February 2020, the Ministry of Health and Family Welfare issued two notifications in the Official Gazette of India, where one was a new definition of Medical Devices, and another was the Medical Devices (Amendment) Rules, 2020. Many more items are included in the meaning of the Medical Devices, such as PPE kits, masks, medical gloves, body bags, cover-all, etc.
Medical Devices Rules and Medical Device Classes
The Medical Devices (Amendment) Rules, 2020, have amended the Medical Devices Rules, 2017 and came into effect on 1st April 2020. With consultation with Drugs Technical Advisory Board (DTAB), the Ministry intended for a cumulative effect of both these notifications to ensure that all medical device classes meet the specific standards of quality and efficacy and for their mandatory registration.
The Central Drugs Standard Control Organisation (CDSCO) enacted the Medical Device Rules, 2017, which came into effect on 1st January 2018. These Rules simplified the regulatory structure for obtaining the registrations and licenses by the manufacturers and importers of all medical device classes, which were first distinguished in the Drugs and Cosmetics Act 1940[1].
Drugs and Cosmetics Act is restricted to only those medical devices that the Government notifies India from time to time under the definition of drugs. Till 11th February 2020, the Indian Government has notified 37 Medical Device Classes as drugs.
Definition of Medical Device
The Definition of a Medical Device as per the Drugs and Cosmetics Act 1940 and Medical Device Rules is as follows:
All devices, including instruments, appliances, apparatus, implants, materials or other articles, alone or in combination, also include software or accessories intended by the manufacturer to be used mainly for animals and humans. It does not achieve the main intended action in or on a human being or animal by any of the pharmacological, immunological or metabolic means. Still, it may assist in the intended function by any of such means for one or more of the fundamental purposes of diagnosis, monitoring, prevention, treatment or alleviation of any disease or disorder; diagnosis, treatment, monitoring, alleviation or assistance for any injury or disability; investigation, replacement, modification, support of anatomy or a physiological process; supporting or sustaining life; disinfection of medical devices and control of conception.
Medical Device Classes
Medical Device (Amendment) Rules, 2020 have done risk-based classification of Medical Devices into:
| Class A | Low Risk |
| Class B | Low Moderate Risk |
| Class C | Moderate High Risk |
| Class D | High Risk |
Different authority issues licences to manufacturers or importers. Here is the list of such licensing authorities with the medical devices:
| Medical device classes | Licensing authority |
| Class A (manufacture) | State Licensing Authority |
| Class B (manufacture) | State Licensing Authority |
| Class C and D (manufacture) | Drugs Controller General of India |
| Class A and B (import) | Drugs Controller General of India |
| Class C and D (import) | Drugs Controller General of India |
Changes in Amended Rules related to Medical Device Classes
A new chapter IIIA with the title Registration of Certain Medical Devices with Sl. No. 7 in the Eight Schedule has been added by the amendment. Changes made by the Medical Device (Amendment) Rules, 2020 are explained as follows:
Requirement of registration
Manufacturers or importers of all classes of medical devices require mandatory registration of their medical devices with the DCGI, Drugs Controller General of India. If a manufacturer or importer fails to obtain such registration, then it will not be able to sell its medical devices in the Indian market. No time limit is prescribed for processing an application for registration by DCGI.
The information that is required to be submitted to obtain registration is as follows:
- Name of company or other entity
- Details of manufacturing site (for medical devices manufactured in India)
- Specification and standards of medical devices (for imported medical devices)
- Details of Medical Devices
- Certificate of compliance concerning ISO 13485
- Free Sale Certificate from origin country (in case of imported devices only)
- Undertaking
Registration is completed upon obtaining the Registration Number. Every manufacturer and importer must display the registration number on its label.
Once a manufacturer or importer registers its medical devices, it has to conform to the Quality Management System (QMS) strictly. If DCGI finds any non-fulfilment of QMS, it has all its right to suspend or cancel the registration.
Requirement of License
Manufacturers and importers of newly notified medical device classes must obtain a license under Medical Device Rules before the prescribed deadline.
Penalty
The Central Licensing Authority (CLA) verifies documents and investigates the quality or safety of medical device classes related to their failure or complaint. In case the registered manufacturer or importer fails to comply with any provision of Medical Device (Amendment) Rules, 2020. CLA first gives an opportunity to show cause, why an order for cancellation of its registration should not be passed, in writing stating the reason thereof, cancels or suspends (for such period as it thinks fit) the registration, either wholly or in respect of any medical device to which the failure relates.
Relaxation
The Indian Government has provided extra time to the medical device industry to transition into the regulatory framework and to obtain the required ISO 13845 Certification. It has also relaxed the requirement of obtaining registration and licenses for all medical device classes for the following periods:
- Voluntary registration to manufacture, import, distribute or sell newly notified medical devices: 1st April 2020 to 1st October 2021.
- Mandatory registration required to import, manufacture, sell or distribute medical devices: after 1st October 2021
- Licenses required to manufacture, import, distribute or sell medical device class A (low risk) and B (medium risk): Before 11th August 2022
- Licenses required to manufacture, import, distribute or sell medical device class C (moderate high risk) and D (high risk): Before 11th August 2023.
If an importer or manufacturer of a medical device fails to obtain the required registration or license before the deadline. In that case, it must stop importing or manufacturing the said medical device until the said registration or license is obtained. As per Medical Device Rules, manufacturing or selling any medical device without a valid license or registration attracts criminal prosecution, including imprisonment for not less than three years and which may be extended to 5 years and a fine of Rs. 1 Lakh or three times of the value of drugs confiscated.
Exemption
Exemption for 37 medical device classes or categories regulated or proposed before 111th February 2020, i.e., the date of the Medical Device Rules Amendment, are not to be affected by this amendment and so do not require to obtain registration.
Effect of Amendment
- The Amendment Rules 2020 are introduced to ensure that every medical device, either manufactured in our country or imported here, has quality assurance before its distribution or sale in the market.
- Many medical devices that are commonly used are covered under these new amended Rules, such as hypodermic syringes and needles, cardiac stents, catheters, perfusion sets, bone cement, lenses, orthopedic implants, sutures, internal prosthetic replacements, etc.
- The timeline for registration or licensing of the medical devices and risk-based medical device classes provides a pause for pharmaceutical companies. It provides a broader scope to test and modify such medical devices that fall under the ambit of the new definition.
Medical Devices Added
The list of medical devices added in the Medical Device (Amendment) Rules, 2020 is as follows:
| Sl. No. | Name of Medical Devices |
| 1. | Disposable Hypodermic Syringes |
| 2. | Disposable Hypodermic Needles |
| 3. | Disposable Perfusion Sets |
| 4. | Substances used for in vitro diagnosis including Blood Grouping Sera |
| 5. | Cardiac Stents |
| 6. | Drug Eluting Stents |
| 7. | Catheters |
| 8. | Intra Ocular Lenses |
| 9. | I.V. Cannula |
| 10. | Bone Cements |
| 11. | Heart Valves |
| 12. | Scalp Vein Set |
| 13. | Orthopaedic Implants |
| 14. | Internal Prosthetic Replacements |
| 15. | Ablation Devices |
| 16. | Ligatures, Sutures and Staplers |
| 17. | Intra Uterine Devices (Cu-T) |
| 18. | Condoms |
| 19. | Tubal Rings |
| 20. | Surgical Dressings |
| 21. | Umbilical tapes |
| 22. | Blood/Blood Component Bags |
| 23. | Organ Preservative Solution |
| 24. | Nebulizer |
| 25. | Blood Pressure Monitoring Device |
| 26. | Glucometer |
| 27. | Digital Thermometer |
| 28. | All implantable medical devices Equipment |
| 29. | CT Scan Equipment |
| 30. | MRI Equipment |
| 31. | Defibrillators |
| 32. | PET Equipment |
| 33. | X-Ray Machine |
| 34. | Dialysis Machine |
| 35. | Bone marrow cell separator |
| 36. | Disinfectants and insecticide |
| 37. | Ultrasound equipment |
Conclusion
Medical Device Classes as per Medical Device (Amendment) Rules, 2020 is classified under Class A, B, C and D. Along with prescribing classes of medical devices, this amendment has added one chapter in previous Medical Device Rules, namely Chapter IIIA: Registration of Certain Medical Devices and has given a new definition of the Medical Devices.
Read our Article:Classification of Medical Devices by CDSCO: An Overview
